Ireland
--:--IST
Recruiting Observational

Study of Tacrolimus Melt-Dose® for Lung Transplant Patients

NCT07042035 · tracked via the Priya Life Science Spain tracker
Sponsor
Chiesi España, S.A.U
Phase
Observational
Started
2024-10-29
Last updated
2025-06-27

Condition(s) studied

Lung TrasplantLung Transplantation

Study summary

To evaluate, under usual clinical practice conditions and with a 12-month follow-up , the most relevant pharmacokinetic parameters of tacrolimus metabolism and safety, in patients with recent lung transplant (unilateral or bilateral) treated with LCPT.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients ≥18 years old. * Patients who have received a first unilateral or bilateral lung transplant. * Patients who have started oral treatment with tacrolimus using the LCPT formulation, with a once-daily dosage within the first 3 months post-transplant. * Patients with a treatment duration expected to be ≥12 months. * The patient (or their representative) can sign the informed consent to participate in the study. Exclusion Criteria: * Patients who have received a multi-organ transplant or have a history of any organ transplant, including lung. * Patients with an estimated survival of \<12 months * Patients diagnosed with cystic fibrosis * Patients diagnosed with scleroderma. * Patients diagnosed with a systemic disease affecting the digestive system. * Patients in any situation or condition that, in the investigator's opinion, makes participation inadvisable, such as any treatment that may interfere with the study. * Patients who are participating or have participated in an interventional research study within 30 days prior to inclusion. * Pregnant women, those planning to become pregnant, or those who are breastfeeding. * Patients who are unable to complete the study. * Patients who have not signed the informed consent.

Primary outcome measure(s)

  • To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety . — 1 year of follow up
    Cmin Tacrolimus dose

Trial sites (2)

FacilityCityRegionStatus
Chiesi España, Torre Realia BCN Plaza Europa 41-43 L'Hospitalet de Llobregat Barcelona Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07042035 on ClinicalTrials.gov ↗ ← All trials in Spain